Device master record means a compilation of records containing the procedures and specifications for a finished device. 器械主记录指一个完整的记录,包括了已经成品医疗器械的程序和规范。 Like the DHF, the DMR applies to a finished device. 就像DHF,DMR适用于一个成品医疗器械。 But the DMR is theDev...
and the medical device raw material suppliers are voluntarily registered. When the medical device applicant needs to use the main document in the application of product listing registration, the owner of the master file shall issue an authorization letter to the medical device applicant, ...
and the medical device raw material suppliers are voluntarily registered. When the medical device applicant needs to use the main document in the application of product listing registration, the owner of the master file shall issue an authorization letter to the medical device applicant, ...
Accurate documentation of medical devices is key to FDA approval. Neusoft had managed its DMR (Device Master Record, data to build the device) and DHR (Device History Record, data on production, e.g. date, quantity, identification label) on paper. After selling the product, the company could...
Decrease in Batch Record Review Time Using Manufacturing Excellence, Dendreon, a pioneer in cellular therapeutics, cut review and release time by almost 50%, while maintaining a right-first-time metric of 99%.Flexible Pricing and Plans for Your Medical Device Company MasterControl solutions are desi...
MEDICAL MASTER OPERATION DEVICEPROBLEM TO BE SOLVED: To provide a medical master operation device in a master/slave system facilitating the operation, dispensing with any special skill level, and easily performing surgery of a micro-region.HATTORI TAKAMASA...
Med Device Manufacturer Kerr Relies on MasterControl for More Efficient Regulatory Processes Ramp up medical device production. Cochlear Helps People Hear with the Help of MasterControl's QMS Demo: MasterControl Device History Record Management Software Customer Demo: Automating Device History Records with...
Minimum of 8-10 years of experience in the medical device industry, with at least 5 years in a leadership role within radiology imaging or similar medical imaging sectors. Proven track record in driving sales growth, managing budgets, and achieving revenue targets in a competitive market. In-...
Full documentation, including design document control, risk management files, design history files, device master records, and quality system guidance documents Technical support and documentation preparation for regulatory submission packages, including premarket approval documents and package filing support Cert...
Medical imaging data can be transmitted from one location to another over the internet or other communication system for recording the data. The filing and record keeping of the images thus received is a problem. It is a labor-intensive and error-prone task to gather information about each disc...